[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)

Study Description

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Brief Summary:

The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.

Condition or disease	Intervention/treatment	Phase
Ovarian Neoplasm	Drug: Pazopanib and paclitaxel	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer
Study Start Date :	July 2012
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	April 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Pazopanib and paclitaxel	Drug: Pazopanib and paclitaxel; Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.

Outcome Measures

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Primary Outcome Measures :

1. Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ]
   Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant

Secondary Outcome Measures :

1. The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ]
   Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
2. The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosis of relapsed ovarian cancer
• Responded to at least on one line of prior platinum based therapy
• Relapsed within platinum resistant interval (≤6months)
• Eastern Cooperative Oncology Group (ECOG) performance status of <2
• Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques

• Satisfactory baseline haematologic and organ function:

  • Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN
  • Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN
  • Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1

Exclusion Criteria:

• Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.

• Treatment with any of the following anti-cancer therapies:

  • radiation therapy 28 days prior to the first dose of pazopanib OR
  • surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
• Treatment with anti-angiogenic therapy
• Presence of gross ascites
• Clinically significant peripheral neuropathy
• Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Southend University Hospital NHS Foundation Trust
Southend, United Kingdom

Sponsors and Collaborators

Imperial College London

GlaxoSmithKline

Investigators

Study Director:	Rohini Sharma, MD	Imperial College London
Principal Investigator:	Timothy Crook, MD	Southend University Hospital NHS Foundation Trust

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT01608009 History of Changes
Other Study ID Numbers:	CRO1627
First Posted:	May 30, 2012
Last Update Posted:	March 10, 2017
Last Verified:	March 2017

Keywords provided by Imperial College London:

platinum resistant; ovarian cancer

Additional relevant MeSH terms:

Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases	Gonadal Disorders; Paclitaxel; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action